Urinary Placement Catheter for Intravesical Devices

Abstract

An inserter assembly (200) for deploying an intravesical device into a urinary bladder of a patient includes a placement catheter (210), a receiving funnel (220), and a stylet (230). The placement catheter defines a lumen extending from a proximal catheter end to an exit opening. The receiving funnel is secured to the placement catheter. The stylet is removably received through the receiving funnel within the lumen. The stylet includes a stylet body and a paddle (238). The stylet body is dimensioned to drive the intravesical device through the lumen and the exit opening into the bladder. The paddle is fixed to the stylet body about the proximal stylet end and is engageable with the receiving funnel. The paddle optionally includes a fitting (242) being lockably engageable with the receiving funnel to removably secure the stylet to the placement catheter.

1 . An inserter assembly for deploying an intravesical device into a urinary bladder of a patient, the inserter assembly comprising:
 a placement catheter defining a lumen, the lumen extending from a proximal catheter end to an exit opening;   a receiving funnel secured to the placement catheter at the proximal catheter end; and   a stylet removably received through the receiving funnel within the lumen of the placement catheter, wherein the stylet comprises (i) a stylet body extending between a proximal stylet end and a distal stylet end, the stylet body being dimensioned to drive the intravesical device through the lumen and the exit opening into the bladder, and (ii) a paddle fixed to the stylet body about the proximal stylet end, wherein the paddle is engageable with the receiving funnel.   
     
     
         2 . The inserter assembly of  claim 1 , wherein the paddle is overmolded about the stylet body at the proximal stylet end, or is integral with the stylet body. 
     
     
         3 . The inserter assembly of  claim 1 , wherein the paddle defines a curved thumb rest at a proximal end, and optionally further defines a curved finger rest opposing the curved thumb rest. 
     
     
         4 . The inserter assembly of  claim 1 , wherein the paddle comprises a grip surface. 
     
     
         5 . The inserter assembly of  claim 1 , wherein the paddle is dimensioned to be received within the receiving funnel. 
     
     
         6 . The inserter assembly of  claim 1 , wherein the paddle comprises a fitting being lockably engageable with the receiving funnel to removably secure the stylet to the placement catheter. 
     
     
         7 . The inserter assembly of  claim 6 , wherein the fitting is engageable with an interior surface of the receiving funnel. 
     
     
         8 . The inserter assembly of  claim 6 , wherein one or both of the fitting and the receiving funnel comprises at least one clip securable to the other of the fitting and the receiving funnel. 
     
     
         9 . The inserter assembly of  claim 6 , wherein the fitting defines a circumferential ridge, and wherein the receiving funnel defines a circumferential channel dimensioned to matingly engage the circumferential ridge. 
     
     
         10 . The inserter assembly of  claim 6 , wherein the fitting is configured to generate audible and/or tactile feedback during engagement with the receiving funnel. 
     
     
         11 . The inserter assembly of  claim 1 , wherein the receiving funnel is overmolded about the proximal catheter end, or is integral with the placement catheter at the proximal catheter end. 
     
     
         12 . The inserter assembly of  claim 1 , wherein the receiving funnel has one or both of an oval profile and an oval perimeter. 
     
     
         13 . The inserter assembly of  claim 1 , wherein the receiving funnel extends asymmetrically in a direction transverse to the stylet body. 
     
     
         14 . The inserter assembly of  claim 1 , wherein the receiving funnel defines a funnel lumen configured to transfer lubricant from the receiving funnel to the lumen of the placement catheter, optionally wherein the receiving funnel is dimensioned to receive at least 1 mL of the lubricant. 
     
     
         15 . The inserter assembly of  claim 14 , wherein the receiving funnel is shaped to facilitate transfer of the lubricant from a packet into the lumen of the placement catheter. 
     
     
         16 . The inserter assembly of  claim 1 , wherein the stylet body has a solid cross-section along an entirety of the stylet body. 
     
     
         17 . The inserter assembly of  claim 1 , wherein the placement catheter is transparent or translucent to visually determine the position of the intravesical device or the stylet within the lumen. 
     
     
         18 . The inserter assembly of  claim 1 , wherein a distal catheter end of the placement catheter comprises (i) a rounded atraumatic tip, and/or (ii) a coudé bend, which optionally is aligned with a major axis of the retrieval funnel such that an orientation of the retrieval funnel is indicative of an orientation of the coudé bend. 
     
     
         19 . The inserter assembly of  claim 1 , wherein the placement catheter comprises depth markings indicative of insertion depth and exit opening orientation. 
     
     
         20 . The inserter assembly of  claim 1 , wherein the placement catheter has (i) a length of from 10 cm to 40 cm, and/or (ii) an outer diameter of from 5 Fr (1.67 mm outer diameter) to 30 Fr (10 mm outer diameter). 
     
     
         21 . The inserter assembly of  claim 1 , wherein one or both of the placement catheter and the stylet include a radiomarker. 
     
     
         22 . The inserter assembly of  claim 1 , wherein one or more of the placement catheter, the paddle, the receiving funnel, and the stylet are formed of the same or different polymeric material. 
     
     
         23 . The inserter assembly of  claim 1 , wherein the paddle comprises:
 a central body portion surrounding the proximal stylet end;   a thumb rest defined at a proximal paddle end; and   a pair of wing portions extending laterally from the central body portion between the thumb rest and a distal paddle end.   
     
     
         24 . The inserter assembly of  claim 23 , wherein the thumb rest has a concave surface facing away from the central body, an oval shaped periphery, or both a concave surface facing away from the central body and an oval shaped periphery. 
     
     
         25 . A kit of parts, comprising:
 an inserter assembly of  claim 1 ; and   an intravesical device suited for introduction into a patient's bladder using the inserter assembly.